Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
KD
Hybrid Global Regulatory Affairs Associate Director – Cardio-Metabolic
Posted 2 months ago
About the role
- Global Regulatory Affairs Associate Director managing regulatory submissions and strategies in a global context. Ensuring compliance and operational efficiency throughout the regulatory process.
Responsibilities
- Lead the implementation of regulatory strategies and operational activities across major global regions.
- Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents.
- Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.
- Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials.
- Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans).
- Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals.
- Develop and implement strategies to minimize review delays and regulatory clock stops.
- Ensure timely and compliant responses to HA queries and requests.
- Contribute to departmental goal setting and lead initiatives to improve regulatory processes.
- Ensure adherence to internal policies, SOPs, and global regulatory requirements.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- Significant experience in regulatory affairs within the pharmaceutical industry.
- Proven track record in project management and regulatory operations.
- Experience representing the organization in cross-functional and cross-cultural settings.
- Strong knowledge of clinical trials, drug development, and regulatory compliance.
- Excellent problem-solving, negotiation, and communication skills.
- Detail-oriented with the ability to manage complex regulatory projects.
- Skilled in risk management and working with cross-functional teams.
- Ability to navigate and influence Health Authority interactions.
- Fluency in English (written and spoken) is essential.
Benefits
- Hybrid (12 days per month on-site if living within 50 miles to our London office)
- Remote (if living beyond 50 miles to our London office)
Job title
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Degree requirement
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